Ph III Study of Sacituzumab Govitecan + Pembro v. Dr. Choice + Pembro in Pts w/ Trip-Neg Breast Ca

UCI Specialty Area: Cancer

Principal Investigator: Ritesh Parajuli

Official Title: A Randomized, Open-Label, Phase III Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced, Inoperable, or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1

A Study On:

Breast

Study Description

The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).

Eligibility

-Participants must be at least 18 years of age

-Participants must have locally advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) who have not received previous systemic therapy for advanced disease and whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening.

-Male and female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.

-Participants who are pregnant or lactating

-Participants who have received prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor.

-Participants who have active serious infection requiring antibiotics.

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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